Interactive Exoskeleton Robot for Walking - Ankle Joint

Stroke Clinical Trial

Official title:

Interactive Exoskeleton Robot for Walking - Ankle Joint

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471248
• Other study ID #: 2015.037-T (Ankle)
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: September 15, 2017
• Start date: May 27, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.

Description:

In this clinical trial, participated stroke patients will be divided into two groups: Robotic group and Sham group. Stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. Robotic group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. A series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2016
• Est. primary completion date: October 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Ischemic or hemorrphagic stroke with drop foot problem.

2. Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination > 21)

3. Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category > 3, Berg Balance Scale > 40)

Exclusion Criteria:

1. Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.

2. Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.

3. Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the follow-up.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Ankle Robot with Power Assistance
Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote gait recovery and physical fitness. They will wear the Ankle Robot during the gait training. The motor will synchronise with the paretic-side gait pattern to provide dorsiflexion moment during swing phase, and free the ankle joint when the sole is loaded.
• Sham
Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote physical fitness. They will wear the Ankle Robot during the gait training. The robot will synchronise with the paretic-side gait pattern to the Ankle Robot provides very low assistance which can be barely perceived by the stroke patient but does not suffice to support the ankle dorsiflexion.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Innovation and Technology Commission, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute Walk Test	Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance	3-month follow-up
Primary	Functional Ambulation Category	Assesses postural stability during various walking tasks	3-month follow-up
Secondary	Timed 10 Meter Walk Test	Assesses walking speed in meters per second over a short duration	3-month follow-up
Secondary	Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity)	Evaluates and measures recovery in post-stroke hemiplegic patients	3-month follow-up
Secondary	Berg Balance Scale	A 14-item objective measure designed to assess static balance and fall risk in adult populations	3-month follow-up
Secondary	Modified Ashworth Scale	Measures spasticity in patients with lesions of the Central Nervous System	3-month follow-up
Secondary	Kinematic and Kinetic Gait Motion Capture	Gait pattern will be recorded when the stroke patient is walking under three conditions: (1) without the Ankle Robot, (2) with the Idle Ankle Robot, and (3) with the Powered Ankle Robot.	3-month follow-up
Secondary	Subjective Feedback Questionnaire	Stroke patients will provide subjective feedback about the performance of the Ankle Robot in terms of safety, effectiveness, and their satisfaction after the gait training	3-month follow-up